| CTRI Number |
CTRI/2025/11/097304 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of likelihood ratio for four characteristic Carcinosin symptoms in Insomnia cases. |
|
Scientific Title of Study
|
Assessment of Likelihood Ratio for Four Characteristic Carcinosin Symptoms in Insomnia Cases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VARSHA KUMARI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, OPD No 18, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata WEST BENGAL 700106 India |
| Phone |
7903064669 |
| Fax |
|
| Email |
varshakumfp@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr PRATIMA PAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, OPD No 18, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata WEST BENGAL 700106 India |
| Phone |
7679507608 |
| Fax |
|
| Email |
dr.pratimapal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr PRATIMA PAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Homoeopathic Materia Medica, OPD No 18, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata WEST BENGAL 700106 India |
| Phone |
7679507608 |
| Fax |
|
| Email |
dr.pratimapal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, GE BLOCK, SECTOR 3, SALT LAKE, KOLKATA 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy, GE BLOCK, SECTOR 3, KOLKATA 700106 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VARSHA KUMARI |
National Institute of Homoeopathy |
Department of Homoeopathic Materia Medica, OPD No 18, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata Kolkata WEST BENGAL |
7903064669
varshakumfp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NATIONAL INSTITUTE OF HOMOEOPATHY - INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CARCINOSIN in insomnia cases |
Doses: As required for patient
Frequency: As per need of patient
Route of administration: Oral
Duration: 6 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participant suffering from insomnia verified by DSM5 criteria
Severity Clinical Insomnia Severity Index (ISI) score more than or equal to 14 (moderate to severe insomnia)
participants aged 18 to 60 years, all sexes.
Subjects of all socioeconomic status, all religions
Ability to understand either Bengali, Hindi, and or English
participants giving written consent to participate in this study
Subjects who agree to undergo laboratory investigation whenever required |
|
| ExclusionCriteria |
| Details |
Participants with unstable psychiatric disorder like severe intellectual disability or autism with severe behavioral disturbances, substance-induced severe psychiatric disorders.
Pregnant women and lactating women.
Immune compromised state like HIV AIDS (low CD4 count), Cancer (hematologic or solid tumors) on active treatment, Chronic kidney failure (end-stage renal disease)
Concurrent medications: Use of hypnotics, sedatives, or stimulants that may interfere with sleep assessment.
Participants who has taken homoeopathic medicines for any chronic illness within 3 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence of selected symptoms of carcinosin in population that suffering from insomnia and improved by carcinosin ,assessment done through ISI [insomnia severity index]. |
At baseline 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of homoeopathic medicines in insomnia
To evaluate the effectiveness of carcinosin or other indicative medicine on quality of life through ORIDL [Outcome Related to Impact on Daily Living]. |
At baseline 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The patient’s information shall be recorded in a standardized case-taking proforma used in NIH, Kolkata (Appendix). Following preliminary screening for insomnia and detailed screening using the specified inclusion and exclusion criteria of the screening proforma (Appendix), eligible patients will be included in the study, followed by recording of baseline scoring data. All eligible patients presenting with insomnia will be prospectively evaluated for the presence of the four characteristic symptoms of Carcinosin, as identified from the Homoeopathic Materia Medica and verified by repertorisation (Appendix). The presence or absence of these characteristic symptoms in each case will be documented systematically. If the patient’s symptom totality shows similarity with Carcinosin and the characteristic symptoms are present, Carcinosin will be prescribed as the indicated remedy. If sufficient similarity is not found, other homoeopathic medicines will be prescribed according to individual indications. The final selection of the medicine will be based on detailed case taking in adherence with standard homoeopathic guidelines - including analysis and evaluation of symptoms, miasmatic diagnosis, framing of symptom totality, and final conclusion with reference to Homoeopathic Materia Medica (Appendix). Individualized dose and potency will be selected based on the susceptibility of the patient. Subsequent prescriptions will be generated in accordance with Kent’s observations on the second prescription and other relevant homoeopathic principles, and will be recorded in follow-up sheets (Appendix). The scoring data will be re-evaluated after 6 months of treatment. Based on the presence or absence of the four characteristic symptoms and the corresponding treatment outcomes, a 2×2 contingency table will be constructed to calculate the Likelihood Ratio (LR) for each characteristic symptom of Carcinosin in insomnia cases, thereby determining its prognostic value in remedy selection. |